• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN IRVINE SILVERHAWK BTK CATHETER, PERIPHERAL, ATHERECTOMY

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COVIDIEN IRVINE SILVERHAWK BTK CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pulmonary Embolism (1498); Death (1802)
Event Date 01/01/2017
Event Type  Death  
Manufacturer Narrative
Study title: a comparative study of percutaneous atherectomy for femoropopliteal arterial occlusive disease yongquan gu, mahmoud malas, lixing qi, lianrui guo, jianming guo, hengxi yu, zhu tong, xixiang gao, jiang zhang, zhonggao wang international angiology 2017 august; 36(4): 340-5 doi: 10. 23736/s0392-9590. 17. 03797-x. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
This article presented a study analyzing the experiences in 160 consecutive patients with femoropopliteal arterial occlusive disease who were treated with silverhawk directional atherectomy devices in one university medical center in china between october 2010 and december 2013. Of the 160 patients treated, 111 (69%) were male. The mean age of patients was 69. 2. 72 patients had de-novo stenotic lesion, 15 patients had de-novo occlusive lesions, 49 patients had in-stent restenosis and 24 patients had in-stent occlusion. All 160 patients underwent silverhawk atherectomy of femoropopliteal artery. Spider fx embolic protection was used in 31 cases. One patient experienced no efficacy due to in-stent thrombosis which was treated with thrombolysis and pta with poor outcome and so bypass surgery was carried out. Below the knee amputations were carried out as a result of a serious foot wound in one patient and in-stent thrombosis in two other patients. One patient died 6 days after the operation due to pulmonary embolization. One patient suffered cerebral infraction following the procedure. In cases where embolic protection was not used, three patients sustained distal artery embolization resulting in thrombectomy and stenting. Three patients with gangrene had auto-amputations of the gangrene toes. Two cases where in-stent thrombosis was not recognized before surgery, required urgent bypass surgery and toe amputation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSILVERHAWK BTK
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
COVIDIEN IRVINE
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
COVIDIEN IRVINE
9775 toledo way
irvine CA 92618
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key6749535
MDR Text Key81226586
Report Number2183870-2017-00320
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K061188
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 06/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/30/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/27/2017 Patient Sequence Number: 1
-
-